Internship: Document Management & Compliance
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.
Our Culture
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.
The role:
We are looking for a motivated Higher Education Intern specializing in document management, organization, and librarian tasks to support our team in the pharmaceutical industry. This is an excellent opportunity to apply your skills in a real-world setting while gaining valuable experience in compliance-driven document structuring.
Proper documentation is essential in the pharmaceutical industry to ensure product quality, regulatory compliance, and operational efficiency. The EudraLex guidelines, particularly Volume 4 – Good Manufacturing Practice (GMP), outlines the necessary principles for maintaining pharmaceutical quality systems. And Eudralex Good Distribution Practice (GDP, Additionally, 21 CFR Part 11 establishes the requirements for electronic records and electronic signatures, ensuring data integrity and security within regulated environments. Adhering to these regulations is crucial for meeting legal obligations, passing audits, and safeguarding patient safety.
Areas of responsibility:
- Create a visual document hierarchy of existing Policies, Procedures, and Work Instructions linked to pharmaceutical quality processes including, but not limited to:
- Quality documentation, changes, deviations, corrective & preventive actions
- In house or outsourced Manufacturing, label and pack
- Analytical analysis, release procedures and trending
- Distribution & warehousing
- Serialization, shortage reporting and recalls
- Enable the identification of gaps in the documentation hierarchy related to undescribed or processes without proper roles and responsibilities
- Liaise with the relevant departments to implement necessary additions to ensure compliance and completeness, to improve titles and searchability within the constraints of Master Control.
- Enable updating the existing training matrices by clearly identifying which roles, from the CEO down to the shop floor operators and which documents need Read and Understood, Exam, or On the Job training.
Your profile:
- Currently pursuing a higher education degree in Library Science, Document Management, Information Management, or a related field.
- Strong analytical and organizational skills with the ability to structure complex information visually and clearly.
- Familiarity with regulatory requirements in the pharmaceutical industry (e.g., Eudralex, 21 CFR Part 11) is a plus.
- Detail-oriented, with the ability to assess gaps and propose structured solutions.
- Proficient in digital tools for document organization and visualization (e.g., Master Control, Microsoft Visio, SharePoint, or similar tools).
What we offer:
- Hands-on experience in the pharmaceutical sector with direct exposure to quality and compliance processes.
- The opportunity to work closely with industry professionals and gain insights into regulatory document management.
- A supportive environment where your contributions directly impact business efficiency and compliance.
- Flexible internship duration both in hours and in duration.
- We provide support and the opportunity to write your thesis or internship report based on the observed and implemented lessons learned, linked to the best practice / theoretical documentation processes taught at the educational institute.
- Appropriate financial compensation